Wednesday, 1 March 2017

#PoliticalSpeak: become an activist and sign our petition

Help us get #EliLilly to disclose the results of their #Tabalumab trial. #PoliticalSpeak #MSBlog

As you are aware we and others hypothesise that MS is caused by a subset of abnormal B-cells that reside in the memory pool. We have developed this hypothesis over many years and it supports the EBV theory of MS. Learning about how MS disease-modifying drugs effects MS is important in supporting, or refuting, our hypothesis. We are particularly interested in the results of the trial below of Tabalumab (LY 2127399) a drug that targets B-cells. Based on other data, and our hypothesis, we predict that this drug will make MS worse, by expanding the particular subset of memory B-cells we are interested in. Predicting worsening of disease is one thing, actually knowing the result of the trial is another thing. MouseDoctor and I have both asked Eli Lilly for the data and they have so far resisted. Is it appropriate for Eli Lilly to keep this data undisclosed?

We note and thank you for you support. We now need to formalise this. You can help us by signing the petition below? The trial involved many sites across the world and if you happen to be a trial participant we would appreciate you telling us. Who knows it may help nudge the Eli Lilly executives to disclose the trial results. Thank you.

Although multiple sclerosis (MS) is considered to be a CD4, Th17-mediated autoimmune disease, supportive evidence is perhaps circumstantial, often based on animal studies, and is questioned by the perceived failure of CD4-depleting antibodies to control relapsing MS. Therefore, it was interestingly to find that current MS-treatments, believed to act via T cell inhibition, including: beta-interferons, glatiramer acetate, cytostatic agents, dimethyl fumarate, fingolimod, cladribine, daclizumab, rituximab/ocrelizumab physically, or functionally in the case of natalizumab, also depleted CD19+, CD27+ memory B cells. This depletion was substantial and long-term following CD52 and CD20-depletion, and both also induced long-term inhibition of MS with few treatment cycles, indicating induction-therapy activity. Importantly, memory B cells were augmented by B cell activating factor (atacicept) and tumor necrosis factor (infliximab) blockade that are known to worsen MS. This creates a unifying concept centered on memory B cells that is consistent with therapeutic, histopathological and etiological aspects of MS.

Please note this is about the science and not taking a shot at Pharma. The experiment has been done and if it was negative, or worse made MS worse, we need to know that so as not to put pwMS at risk in the future and to save money and time in not repeating experiments unnecessarily.

Eli Lilly may have learnt a lot about MS from this study and are using the information to design their next drug. If that is the case we are unlikely to get the data. If not the the community needs to know.

Thank you for posting this survey. Completed. Will try and encourage family, friends and other pwMS to do likewise. Great to see you've already heard from some trial participants, they must be especially keen to know what happened.

Prof G, it is in fact unethical to repeat failed experiments in patients and how can repeat blunders be avoided if the results of failed studies are not published? We are not taking a shot at anybody, but there is a certain collective responsibility in medical science.

This is a good example why pharma should be taken to task and the rules changed. In the age of information this data should not be allowed not to surface properly Importantly it should not be allowed not to surface within a rasonable time frame.. People have risked their lifes to create the information. For it to languish in a bottom drawer is terrible A negative result can be as informative as a positive result, which is why we do not pressure people in the lab to get a certain answer.

That is the nature of science

Pharma will say it costs money to do this but the data is already analyed they know if it works or not, so publish it

Give the data to an academic and they will publish it for free. Indeed we are paying open access costs. This way pharma dont have to pay a new car for some medical publisher to write the paper.

Down side is then pharma can't control what is said ..

Would you let me loose with clinical trial data?Current pharma is saying No!

Somebody on shift.ms mentioned alltrials.net (it looks like people are getting fairly furious about unpublished trial results). At least some people. Maybe EliLilly could turn it into a nice and positive gesture for the companyand declare that they are going to do all they can for their customers (oops! patients) from now on and make all results available? ;-)

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